Establishment and optimization of the method for related substances in myristyl alcohol
10.19778/j.chp.2025.02.008
- VernacularTitle:药用辅料十四醇中有关物质测定方法的建立
- Author:
Xinxin FANG
1
;
Chuanmei HU
1
;
Cuixia YAN
1
;
Hong SHAO
1
;
Luxia ZHENG
1
Author Information
1. 上海市食品药品检验研究院,上海 201203
- Publication Type:Journal Article
- Keywords:
GC;
myristyl alcohol;
lauryl alcohol;
cetyl alcohol;
related substance
- From:
Drug Standards of China
2025;26(2):162-166
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a GC method for the determination of related substances in myristyl alcohol.Methods:Use a column packed with polyethylene glycol as the stationary phase(HP-INNOWAX,0.25 mm×30 m,0.25 μm).Maintain the column temperature at 90℃,raise the temperature to 180℃by 5℃per minutes,maintain for 25 minutes.The temperatures of injection port is 270℃.The temperatures of detector is 280℃.Cal-culate the content by normalization method.Result:Lauryl alcohol,myristyl alcohol,pentadecanol,cetyl alcohol,stearyl alcohol and oleyl alcohol showed good linear relationships within the ranges of 6.2-123.8,4.2-134.2,5.2-104.2,4.5-90.3,4.8-96.0,4.8-95.2 μg·mL-1,respectively,with the correlation coefficient above 0.999 8.The limit of detection of aforementioned fatty alcohols were 0.2,0.2,0.2,0.3,0.5 and 0.5 μg·mL-1,which were more sensitive than the method in USP monotherapy Myristyl Alcohol.The content of lauryl alcohol was 0.2%-0.6%and that of cetyl alcohol was 0.1%-0.9%in 5 batches of samples.Sum of re-lated fatty alcohols and unspecified impurities was 0.7%-2.5%.Conclusion:The method established in this study has good separation effect,high specificity and high sensitivity,and solved the problem of difficult identifica-tion of related fatty alcohols caused by high noise at the baseline of the method in USP monotherapy myristyl alco-hol.It can be used for the the determination of related substances in myristyl alcohol.It also provides reference and guidance for the quality management and control of other fatty alcohols.
